Probiotic agents are organisms that confer a benefit when they grow in a particular environment, often by inhibiting the growth of other biological organisms in the same environment. Examples of probiotics include bacteria and bacteriophages which can grow in the intestine, at least temporarily, to displace or destroy pathogens and provide other benefits to the host organism (Salminen et al, Antonie Van Leeuwenhoek, 70 (2–4): 347–358, 1996; Elmer et al, JAMA, 275:870–876, 1996; Rafter, Scand. J. Gastroenterol. 30:497–502, 1995; Perdigon et al, J. Dairy Sci., 78:1597–1606, 1995; Gandi, Townsend Lett. Doctors & Patients, pp. 108–110, January 1994; Lidbeck et al, Eur. J. Cancer Prev. 1:341–353, 1992).
The therapeutic use of probiotic bacteria, especially Lactobacillus strains, that colonize the gut has been previously disclosed (Winberg et al, Pediatr. Nephrol. 7:509–514, 1993; Malin et al, Ann. Nutr. Metab. 40:137–145, 1996; and U.S. Pat. No. 5,176,911).
Lactic acid producing bacteria (e.g., Bacillus, Lactobacillus and Streptococcus species) have been used as food additives and there have been some claims that they provide nutritional and therapeutic value (Gorbach, Ann. Med. 22:37–41, 1990; Reid et al, Clin. Microbiol. Rev., 3:335–344, 1990).
Bacillus coagulans is a non-pathogenic gram positive spore-forming bacteria that produces L(+) lactic acid (dextrorotatory) in homofermentation conditions. It has been isolated from natural sources, such as heat-treated soil samples inoculated into nutrient medium (Bergey's Manual of Systemic Bacteriology, Vol. 2, Sneath, P. H. A. et al., eds., Williams & Wilkins, Baltimore, Md., 1986). Purified B. coagulans strains have served as a source of enzymes including endonucleases (e.g., U.S. Pat. No. 5,200,336), amylase (U.S. Pat. No. 4,980,180), lactase (U.S. Pat. No. 4,323,651) and cyclo-malto-dextrin glucano-transferase (U.S. Pat. No. 5,102,800). B. coagulans has been used to produce lactic acid (U.S. Pat. No. 5,079,164). A strain of B. coagulans (referred to as L. sporogenes Sakaguti & Nakayama (ATCC 31284)) has been combined with other lactic acid producing bacteria and B. natto to produce a fermented food product from steamed soybeans (U.S. Pat. No. 4,110,477). B. coagulans strains have also been used as animal feeds additives for poultry and livestock to reduce disease and improve feed utilization and, therefore, to increase growth rate in the animals (International PCT Pat. Applications No. WO 9314187 and No. WO 9411492).
In particular, B. coagulans strains have been used to reduce serum cholesterol in certain formulations (Mohan et al, Indian J. Medical Research, 92:431–432, 1990), although this approach did not reduce triglycerides sufficiently and resulted in excessive reductions on “good” cholesterol, e.g., high density lipoprotein (HDL).
Supplementation of diet with fructo-oligosaccharides (FOS) have been reported to provide health benefits including reduction of serum triglycerides. Mitsuoka et al, Nutrition Research, 4:961–966, 1984.
However, there remains a need for control of cholesterol to treat cholesterol related diseases.